Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions
Identifieur interne : 000138 ( Pmc/Corpus ); précédent : 000137; suivant : 000139Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions
Auteurs : Luciana Verçoza Viana ; Marilia Brito Gomes ; Lenita Zajdenverg ; Elizabeth Joao Pavin ; Mirela Jobim AzevedoSource :
- Trials [ 1745-6215 ] ; 2016.
Abstract
Brazilian records on glycemic control in patients with type 1 diabetes show treatment efficacy. Poor patient adherence to therapeutic proposals influences these results and can be associated with social, psychological, and economic aspects, besides others factors. The aim of this study was to evaluate the efficacy of psychological, telecare, and educational interventions to improve treatment compliance among patients with type 1 diabetes. Compliance was assessed indirectly using reduction of glycated hemoglobin (HbA1c) as the principal outcome measure.
Systematic review and meta-analyses of randomized controlled clinical trials (RCTs) were performed using Medline, Embase, Cochrane and Scopus databases up to April 2015. The following medical subject headings were used: Diabetes Mellitus, Type 1, Patient Compliance or Adherence, Hemoglobin A, glycated, and Randomized Controlled Trial. The principal outcome was change in HbA1c between baseline and follow-up. Where appropriate, trials were combined in meta-analysis using fixed effects models.
From 191 articles initially identified, 57 were full text reviewed, and 19 articles met the inclusion criteria providing data from 1782 patients (49.4 % males, age 18 years). The RCTs (2 to 24 months in duration) were divided into four groups according to type of intervention: psychology (seven studies; 818 patients), telecare (six studies; 494 patients); education (five studies; 349 patients), and psychoeducation (one study; 153 patients). All studies reported some type of adherence measurement of the interventions. Decrease in HbA1c was observed after psychology (MD −0.310; 95 % CI, −0.599 to −0.0210,
Psychological approaches to improve adherence to diabetes care treatment modestly reduced HbA1c in patients with type 1 diabetes; telecare and education interventions did not change glycemic control. However, the limited number of studies included as well as their methodological quality should be taken into account.
The online version of this article (doi:10.1186/s13063-016-1207-6) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-016-1207-6
PubMed: 26888087
PubMed Central: 4758163
Links to Exploration step
PMC:4758163Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions</title><author><name sortKey="Viana, Luciana Vercoza" sort="Viana, Luciana Vercoza" uniqKey="Viana L" first="Luciana Verçoza" last="Viana">Luciana Verçoza Viana</name><affiliation><nlm:aff id="Aff1">Endocrinology Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, Prédio 12, 4° andar, 90035-003 Porto Alegre, RS Brazil</nlm:aff></affiliation></author><author><name sortKey="Gomes, Marilia Brito" sort="Gomes, Marilia Brito" uniqKey="Gomes M" first="Marilia Brito" last="Gomes">Marilia Brito Gomes</name><affiliation><nlm:aff id="Aff2">Unit of Diabetes, Universidade Estadual do Rio de Janeiro, Rio de Janeiro, Brazil</nlm:aff></affiliation></author><author><name sortKey="Zajdenverg, Lenita" sort="Zajdenverg, Lenita" uniqKey="Zajdenverg L" first="Lenita" last="Zajdenverg">Lenita Zajdenverg</name><affiliation><nlm:aff id="Aff3">Internal Medicine Department, Diabetes Division, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil</nlm:aff></affiliation></author><author><name sortKey="Pavin, Elizabeth Joao" sort="Pavin, Elizabeth Joao" uniqKey="Pavin E" first="Elizabeth Joao" last="Pavin">Elizabeth Joao Pavin</name><affiliation><nlm:aff id="Aff4">Department of Clinical Medicine, Universidade Estadual de Campinas, Campinas, Brazil</nlm:aff></affiliation></author><author><name sortKey="Azevedo, Mirela Jobim" sort="Azevedo, Mirela Jobim" uniqKey="Azevedo M" first="Mirela Jobim" last="Azevedo">Mirela Jobim Azevedo</name><affiliation><nlm:aff id="Aff1">Endocrinology Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, Prédio 12, 4° andar, 90035-003 Porto Alegre, RS Brazil</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26888087</idno><idno type="pmc">4758163</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4758163</idno><idno type="RBID">PMC:4758163</idno><idno type="doi">10.1186/s13063-016-1207-6</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000138</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000138</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions</title><author><name sortKey="Viana, Luciana Vercoza" sort="Viana, Luciana Vercoza" uniqKey="Viana L" first="Luciana Verçoza" last="Viana">Luciana Verçoza Viana</name><affiliation><nlm:aff id="Aff1">Endocrinology Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, Prédio 12, 4° andar, 90035-003 Porto Alegre, RS Brazil</nlm:aff></affiliation></author><author><name sortKey="Gomes, Marilia Brito" sort="Gomes, Marilia Brito" uniqKey="Gomes M" first="Marilia Brito" last="Gomes">Marilia Brito Gomes</name><affiliation><nlm:aff id="Aff2">Unit of Diabetes, Universidade Estadual do Rio de Janeiro, Rio de Janeiro, Brazil</nlm:aff></affiliation></author><author><name sortKey="Zajdenverg, Lenita" sort="Zajdenverg, Lenita" uniqKey="Zajdenverg L" first="Lenita" last="Zajdenverg">Lenita Zajdenverg</name><affiliation><nlm:aff id="Aff3">Internal Medicine Department, Diabetes Division, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil</nlm:aff></affiliation></author><author><name sortKey="Pavin, Elizabeth Joao" sort="Pavin, Elizabeth Joao" uniqKey="Pavin E" first="Elizabeth Joao" last="Pavin">Elizabeth Joao Pavin</name><affiliation><nlm:aff id="Aff4">Department of Clinical Medicine, Universidade Estadual de Campinas, Campinas, Brazil</nlm:aff></affiliation></author><author><name sortKey="Azevedo, Mirela Jobim" sort="Azevedo, Mirela Jobim" uniqKey="Azevedo M" first="Mirela Jobim" last="Azevedo">Mirela Jobim Azevedo</name><affiliation><nlm:aff id="Aff1">Endocrinology Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, Prédio 12, 4° andar, 90035-003 Porto Alegre, RS Brazil</nlm:aff></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Brazilian records on glycemic control in patients with type 1 diabetes show treatment efficacy. Poor patient adherence to therapeutic proposals influences these results and can be associated with social, psychological, and economic aspects, besides others factors. The aim of this study was to evaluate the efficacy of psychological, telecare, and educational interventions to improve treatment compliance among patients with type 1 diabetes. Compliance was assessed indirectly using reduction of glycated hemoglobin (HbA1c) as the principal outcome measure.</p></sec><sec><title>Methods</title><p>Systematic review and meta-analyses of randomized controlled clinical trials (RCTs) were performed using Medline, Embase, Cochrane and Scopus databases up to April 2015. The following medical subject headings were used: Diabetes Mellitus, Type 1, Patient Compliance or Adherence, Hemoglobin A, glycated, and Randomized Controlled Trial. The principal outcome was change in HbA1c between baseline and follow-up. Where appropriate, trials were combined in meta-analysis using fixed effects models.</p></sec><sec><title>Results</title><p>From 191 articles initially identified, 57 were full text reviewed, and 19 articles met the inclusion criteria providing data from 1782 patients (49.4 % males, age 18 years). The RCTs (2 to 24 months in duration) were divided into four groups according to type of intervention: psychology (seven studies; 818 patients), telecare (six studies; 494 patients); education (five studies; 349 patients), and psychoeducation (one study; 153 patients). All studies reported some type of adherence measurement of the interventions. Decrease in HbA1c was observed after psychology (MD −0.310; 95 % CI, −0.599 to −0.0210, <italic>P</italic> = 0.035) but not after telecare (MD −0.124 %; 95 % CI, −0.268, 0.020; <italic>P</italic> = 0.090) or educational (MD −0.001; 95 % CI, −0.202, 0.200; <italic>P</italic> = 0.990) interventions.</p></sec><sec><title>Conclusion</title><p>Psychological approaches to improve adherence to diabetes care treatment modestly reduced HbA1c in patients with type 1 diabetes; telecare and education interventions did not change glycemic control. However, the limited number of studies included as well as their methodological quality should be taken into account.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-016-1207-6) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="De Boer, Ih" uniqKey="De Boer I">IH de Boer</name></author><author><name sortKey="Sun, W" uniqKey="Sun W">W Sun</name></author><author><name sortKey="Cleary, Pa" uniqKey="Cleary P">PA Cleary</name></author><author><name sortKey="Lachin, Jm" uniqKey="Lachin J">JM Lachin</name></author><author><name sortKey="Molitch, Me" uniqKey="Molitch M">ME Molitch</name></author><author><name sortKey="Steffes, Mw" uniqKey="Steffes M">MW Steffes</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-id journal-id-type="iso-abbrev">Trials</journal-id><journal-title-group><journal-title>Trials</journal-title></journal-title-group><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26888087</article-id><article-id pub-id-type="pmc">4758163</article-id><article-id pub-id-type="publisher-id">1207</article-id><article-id pub-id-type="doi">10.1186/s13063-016-1207-6</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group></article-categories><title-group><article-title>Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Viana</surname><given-names>Luciana Verçoza</given-names></name><address><phone>+ 55 51 3359 8127</phone><email>vercoza@yahoo.com</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Gomes</surname><given-names>Marilia Brito</given-names></name><address><email>mariliabgomes@gmail.com</email></address><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Zajdenverg</surname><given-names>Lenita</given-names></name><address><email>lenitazaj@gmail.com</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Pavin</surname><given-names>Elizabeth Joao</given-names></name><address><email>ejpavin@gamil.com</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Azevedo</surname><given-names>Mirela Jobim</given-names></name><address><email>mjazevedo@gmail.com</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><collab>On Behalf of the Brazilian Type 1 Diabetes Study Group (BrazDiab1SG)</collab></contrib><aff id="Aff1"><label></label>Endocrinology Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos 2350, Prédio 12, 4° andar, 90035-003 Porto Alegre, RS Brazil</aff><aff id="Aff2"><label></label>Unit of Diabetes, Universidade Estadual do Rio de Janeiro, Rio de Janeiro, Brazil</aff><aff id="Aff3"><label></label>Internal Medicine Department, Diabetes Division, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil</aff><aff id="Aff4"><label></label>Department of Clinical Medicine, Universidade Estadual de Campinas, Campinas, Brazil</aff></contrib-group><pub-date pub-type="epub"><day>17</day><month>2</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>17</day><month>2</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>17</volume><elocation-id>94</elocation-id><history><date date-type="received"><day>5</day><month>5</month><year>2015</year></date><date date-type="accepted"><day>30</day><month>1</month><year>2016</year></date></history><permissions><copyright-statement>© Viana et al. 2016</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>Brazilian records on glycemic control in patients with type 1 diabetes show treatment efficacy. Poor patient adherence to therapeutic proposals influences these results and can be associated with social, psychological, and economic aspects, besides others factors. The aim of this study was to evaluate the efficacy of psychological, telecare, and educational interventions to improve treatment compliance among patients with type 1 diabetes. Compliance was assessed indirectly using reduction of glycated hemoglobin (HbA1c) as the principal outcome measure.</p></sec><sec><title>Methods</title><p>Systematic review and meta-analyses of randomized controlled clinical trials (RCTs) were performed using Medline, Embase, Cochrane and Scopus databases up to April 2015. The following medical subject headings were used: Diabetes Mellitus, Type 1, Patient Compliance or Adherence, Hemoglobin A, glycated, and Randomized Controlled Trial. The principal outcome was change in HbA1c between baseline and follow-up. Where appropriate, trials were combined in meta-analysis using fixed effects models.</p></sec><sec><title>Results</title><p>From 191 articles initially identified, 57 were full text reviewed, and 19 articles met the inclusion criteria providing data from 1782 patients (49.4 % males, age 18 years). The RCTs (2 to 24 months in duration) were divided into four groups according to type of intervention: psychology (seven studies; 818 patients), telecare (six studies; 494 patients); education (five studies; 349 patients), and psychoeducation (one study; 153 patients). All studies reported some type of adherence measurement of the interventions. Decrease in HbA1c was observed after psychology (MD −0.310; 95 % CI, −0.599 to −0.0210, <italic>P</italic> = 0.035) but not after telecare (MD −0.124 %; 95 % CI, −0.268, 0.020; <italic>P</italic> = 0.090) or educational (MD −0.001; 95 % CI, −0.202, 0.200; <italic>P</italic> = 0.990) interventions.</p></sec><sec><title>Conclusion</title><p>Psychological approaches to improve adherence to diabetes care treatment modestly reduced HbA1c in patients with type 1 diabetes; telecare and education interventions did not change glycemic control. However, the limited number of studies included as well as their methodological quality should be taken into account.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-016-1207-6) contains supplementary material, which is available to authorized users.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Adherence</kwd><kwd>Non-pharmacological interventions</kwd><kwd>Type 1 diabetes</kwd><kwd>Systematic review</kwd><kwd>Meta-analyses</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2016</meta-value></custom-meta></custom-meta-group></article-meta></front><body><sec id="Sec1" sec-type="introduction"><title>Background</title><p>A seminal study published in recent decades clearly demonstrated that intensive glycemic treatment promoting lower glycated hemoglobin (HbA1c) values, as compared to standard care, can prevent or postpone chronic diabetic complications [<xref ref-type="bibr" rid="CR1">1</xref>]. Furthermore, follow-up of these patients after the end-of-studies demonstrated that past strict glycemic control was associated with a low prevalence of complications years later. Patients intensively treated early in the course of type 1 diabetes less frequently developed impaired glomerular filtration rate [<xref ref-type="bibr" rid="CR2">2</xref>], increased urinary albumin excretion [<xref ref-type="bibr" rid="CR2">2</xref>, <xref ref-type="bibr" rid="CR3">3</xref>], and also had a lower risk of cardiovascular disease [<xref ref-type="bibr" rid="CR4">4</xref>] than those treated with conventional diabetes therapy. Reduction in the risk of cardiovascular, renal, and ocular disease by strict glycemic control was recently reinforced in a systematic review in these patients [<xref ref-type="bibr" rid="CR5">5</xref>].</p><p>HbA1c measurement has been widely used to evaluate glycemic control in patients with diabetes. It reflects the average glycemia over several months [<xref ref-type="bibr" rid="CR6">6</xref>] and should be measured every 3 months. Whenever possible HbA1c targets should be maintained as close as possible to the non-diabetic levels (<6.5 %) but goals must be individualized by age and by the presence of chronic diabetic complications [<xref ref-type="bibr" rid="CR7">7</xref>]. Diabetes management requires adherence to a complex daily therapeutic regimen in order to reduce HbA1c levels. Patients have to be able to adhere to many procedures such as self-blood glucose monitoring, diet plan, insulin administration and dose titration, and exercise [<xref ref-type="bibr" rid="CR6">6</xref>].</p><p>Although epidemiological data on patients with type 1 diabetes in Brazil are still scarce, incidence seems to be increasing (incidence rate of 18.49/100,000) [<xref ref-type="bibr" rid="CR8">8</xref>]. Indeed, the direct medical costs of type 1 diabetes in Brazil are about US$1319.15 per patient for our national health service, not including the expenditure on chronic diabetic complications [<xref ref-type="bibr" rid="CR9">9</xref>]. This aspect is relevant since the majority of our patients are at high risk of developing chronic diabetic complications. A survey conducted in 573 patients with type 1 diabetes in the south of Brazil demonstrated a high prevalence of diabetic retinopathy (43.3 %) and diabetic kidney disease (34.5 %) [<xref ref-type="bibr" rid="CR10">10</xref>].</p><p>Despite advances in therapeutics, poor glycemic control is still a reality in many type 1 diabetic patients [<xref ref-type="bibr" rid="CR11">11</xref>, <xref ref-type="bibr" rid="CR12">12</xref>]. Accordingly, up to 78 % of Brazilian patients with type 1 diabetes do not attain glycemic targets. Table <xref rid="Tab1" ref-type="table">1</xref> shows mean HbA1c and the percentage of patients with type 1 diabetes who attain glycemic targets in different Brazilians centers.<table-wrap id="Tab1"><label>Table 1</label><caption><p>Mean glycated hemoglobin (HbA1c) and percentage of patients with type 1 diabetes who are on glycemic target in Brazilian centers</p></caption><table frame="hsides" rules="groups"><thead><tr><th rowspan="2">Author</th><th rowspan="2">Number</th><th rowspan="2">Region of Brazil</th><th>HbA1c (%)</th><th rowspan="2">Percentage of patients on glycemic target*</th></tr><tr><th>(mean ± SD)</th></tr></thead><tbody><tr><td>Rodrigues et al. 2010 [<xref ref-type="bibr" rid="CR10">10</xref>]<sup>a</sup></td><td>573</td><td>South</td><td>9.0 ± 3.9</td><td>22.0 %</td></tr><tr><td>Mendes et al. 2010 [<xref ref-type="bibr" rid="CR49">49</xref>]<sup>b</sup></td><td>979</td><td>South, Southeast, Northeast, Middle-west</td><td>-</td><td>7.0 %</td></tr><tr><td>Gomes et al. 2012 [<xref ref-type="bibr" rid="CR50">50</xref>]<sup>c</sup></td><td>3591</td><td>South, Southeast, North/Northeast, Middle-west</td><td>9.1 ± 2.3 to 9.4 ± 2.6</td><td>12.2 to 21.4 %</td></tr><tr><td>Gomes et al. 2012 [<xref ref-type="bibr" rid="CR51">51</xref>]<sup>d</sup></td><td>1774</td><td>South, Southeast, North/Northeast, Middle-west</td><td>9.1 ± 2.2</td><td>11.6 %</td></tr><tr><td>Viana et al. 2013 [<xref ref-type="bibr" rid="CR52">52</xref>]<sup>e</sup></td><td>1026</td><td>South, Southeast, North/Northeast, Middle-west</td><td>9.3 ± 2.3</td><td>13.0 %</td></tr></tbody></table><table-wrap-foot><p>*Glycemic targets: <sup>a, b, e</sup>HbA1c <7.0 %; <sup>c, d</sup>HbA1c <7 % – adults, HbA1c <7.5 % – 13 to 19 years, HbA1c < 8 % – 6 to 12 years, HbA1c >7.5 % and HbA1c <8.5 % – < 6 years</p></table-wrap-foot></table-wrap></p><p>Poor compliance with diabetes treatment is probably an important determinant of poor glycemic control observed in patients with type 1 diabetes. As adherence to treatment increases, HbA1c decreases as demonstrated by a meta-analysis of 21 cross-sectional studies including 2492 youth with type 1 diabetes [<xref ref-type="bibr" rid="CR13">13</xref>]. Multicomponent adherence or self-management promoting interventions seems to be more potent than single ones, although with a borderline beneficial effect on HbA1c [<xref ref-type="bibr" rid="CR14">14</xref>]. Many factors have been associated with adherence to diabetes treatment and glycemic control such as economic status [<xref ref-type="bibr" rid="CR15">15</xref>], access to diabetes care [<xref ref-type="bibr" rid="CR16">16</xref>] and devices to self-monitor blood glucose [<xref ref-type="bibr" rid="CR17">17</xref>], family support [<xref ref-type="bibr" rid="CR18">18</xref>], social and peer pressures [<xref ref-type="bibr" rid="CR19">19</xref>], interactions with their health-care providers [<xref ref-type="bibr" rid="CR16">16</xref>], presence of depression [<xref ref-type="bibr" rid="CR18">18</xref>], and transition to adolescence [<xref ref-type="bibr" rid="CR18">18</xref>–<xref ref-type="bibr" rid="CR20">20</xref>]. In this sense, non-pharmacological strategies for improving adherence to diabetes care, resulting in improved glycemic control, have been studied: psychological [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR29">29</xref>], telecare or Internet-based [<xref ref-type="bibr" rid="CR30">30</xref>–<xref ref-type="bibr" rid="CR35">35</xref>], educational [<xref ref-type="bibr" rid="CR26">26</xref>, <xref ref-type="bibr" rid="CR36">36</xref>–<xref ref-type="bibr" rid="CR38">38</xref>], and psychoeducational [<xref ref-type="bibr" rid="CR39">39</xref>] interventions. Although other meta-analyses [<xref ref-type="bibr" rid="CR30">30</xref>, <xref ref-type="bibr" rid="CR40">40</xref>], have already examined the effect of non-pharmacological interventions on compliance with diabetes treatment, the efficacy of such strategies is still uncertain.</p><p>Considering the poor glycemic control, the high prevalence of chronic diabetic complications, and the increasing worldwide prevalence of type 1 diabetes among children and adolescents [<xref ref-type="bibr" rid="CR41">41</xref>, <xref ref-type="bibr" rid="CR42">42</xref>] it is crucial to identify factors that improve adherence to diabetes treatment. The aim of this study was to evaluate the efficacy of psychological, telecare, and educational interventions to improve treatment compliance among patients with type 1 diabetes. Compliance was assessed indirectly using reduction of HbA1c as the principal outcome measure.</p></sec><sec id="Sec2" sec-type="materials|methods"><title>Methods</title><p>This systematic review was carried out using a protocol constructed according to the Cochrane Handbook recommendations [<xref ref-type="bibr" rid="CR43">43</xref>] and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [<xref ref-type="bibr" rid="CR44">44</xref>] (Additional file <xref rid="MOESM1" ref-type="media">1</xref>).</p><sec id="Sec3"><title>Data sources and searches</title><p>We searched databases from Medline, Embase, Cochrane, and Scopus to identify randomized controlled clinical trials (RCTs) that reported non-pharmacological interventions to improve adherence to diabetes treatment in patients with type 1 diabetes up to April 2015. The initial search comprised the following medical subject headings: <italic>“Diabetes Mellitus, Type 1” [Mesh], “Patient Compliance” [Mesh], or Adherence</italic>, <italic>“Hemoglobin A, Glycated” [Mesh],</italic> and related entry terms associated with a high sensitivity strategy for the search of RCTs available at <ext-link ext-link-type="uri" xlink:href="http://www.sign.ac.uk/methodology/filters.html#random">http://www.sign.ac.uk/methodology/filters.html#random</ext-link> (see <xref ref-type="sec" rid="Sec17">Appendix</xref> section). All potentially eligible studies were considered for review, limited to the English, Spanish, or Portuguese language. A manual search was also performed in the reference lists of included articles.</p></sec><sec id="Sec4"><title>Study selection</title><p>We included RCTs that reported changes in the HbA1c as differences between final and baseline interventions in RCTs. We excluded studies if they were not randomized, were crossover trials, included patients with type 1 and type 2 diabetes being analyzed together, included pregnant patients, or had no information about HbA1c.</p></sec><sec id="Sec5"><title>Data extraction and quality assessment</title><p>All citations retrieved from electronic databases were imported to the EndNote Program. Two reviewers (MJA, LVV) independently analyzed the titles and abstracts of every paper retrieved from the literature search to identify potentially eligible studies. All studies that did not meet the inclusion criteria were excluded. The full text of the remaining papers was obtained for further examination. The same two reviewers using a standardized data extraction form independently extracted data of the included studies. Extracted data included first author’s name, year of publication, number of participants, details of the study design (i.e., randomization method), trial duration, and patient characteristics (age, gender, ethnicity, diabetes duration). Studies were divided into four categories according to the type of intervention: psychology, telecare, education, and psychoeducation. Briefly, telecare intervention was defined as teleconsultation, tele-expertise, or telemonitoring [<xref ref-type="bibr" rid="CR45">45</xref>]. Behavioral, multisystemic, and motivational approaches were considered a psychological intervention and any structured educational program as an educational intervention. Psychoeducation intervention was defined when psychological and educational tools were implemented at the same intervention.</p><p>Methodological quality assessment of included RCTs was independently assessed by the same two reviewers (MJA, LVV). We used the Cochrane Collaboration tool for assessing risk of bias of every included study. According to the Cochrane Collaboration, biases were classified into six domains: selection, performance, detection, attrition, reporting, and other [<xref ref-type="bibr" rid="CR43">43</xref>, <xref ref-type="bibr" rid="CR46">46</xref>]. The risk of bias for each domain was classified as high, low, or unclear.</p></sec><sec id="Sec6"><title>Data synthesis and analysis</title><p>Descriptive data from the systematic review were presented as mean and/or range, when available. We analyzed HbA1c (%) as a continuous variable and reported HbA1c changes as absolute differences between arithmetic means at baseline and end-of-study and mean differences (MD) were used in the analyses (fixed models).</p><p>The heterogeneity between the studies was evaluated by Cochran’s chi-squared test (<italic>Q</italic> test) and a <italic>P</italic> value for trend ≤0.10 was considered statistically significant. The <italic>I</italic><sup><italic>2</italic></sup> test was also performed to evaluate the magnitude of heterogeneity [<xref ref-type="bibr" rid="CR47">47</xref>] and statistical heterogeneity was considered in the presence of <italic>I</italic><sup><italic>2</italic></sup> values >75 %. Subgroup analyses were performed including only RCTs conducted with children and teenagers.</p><p>All statistical analyses will be performed using Stata 11.0 software (StataCorp, College Station, TX, USA). Significance was set at <italic>P</italic> <0.05 and 95 % confidence intervals are quoted throughout.</p></sec></sec><sec id="Sec7" sec-type="results"><title>Results</title><sec id="Sec8"><title>Literature search</title><p>We identified 191 studies in database searches. Of these, 67 studies were excluded due to duplication. Another 67 articles were excluded based on title or abstract: 24 studies were not performed in patients with type 1 diabetes; 31 studies had no information about treatment compliance; seven studies did not report HbA1c; and five studies had a non-randomized design. Then we evaluated the full texts of 57 articles. Two additional papers identified in the references of the revised articles were also fully evaluated. Hence, from a total of 57 studies, 40 were excluded and 19 trials, which fulfilled all selection criteria, were included in the current systematic review (Fig. <xref rid="Fig1" ref-type="fig">1</xref>).<fig id="Fig1"><label>Fig. 1</label><caption><p>Flow diagram of literature search to identify randomized clinical trials evaluating interventions to improve compliance with lower glycated hemoglobin (HbA1c) values in patients with type 1 diabetes</p></caption><graphic xlink:href="13063_2016_1207_Fig1_HTML" id="MO1"></graphic></fig></p></sec><sec id="Sec9"><title>Study characteristics</title><p>This systematic review included a total of 1782 patients with type 1 diabetes aged 18 years (12 to 46), 49.4 % males, 71.6 % of white ethnicity, and with a mean duration of diabetes of 9.3 years (3.7 to 23). Baseline mean HbA1c in intervention groups ranged from 8.2 % to 11.4 % and from 8.2 % to 11.3 % in the control groups. Trial duration varied from 2 to 24 months.</p><p>RCT characteristics according to each intervention category are described in Table <xref rid="Tab2" ref-type="table">2</xref>. Table <xref rid="Tab3" ref-type="table">3</xref> depicts risk of bias in each individual RCT evaluating interventions to improve compliance with lower HbA1c in patients with type 1 diabetes. Most of the quality domains of studies included in these meta-analyses revealed a low or uncertain bias risk.<table-wrap id="Tab2"><label>Table 2</label><caption><p>Characteristics of included randomized clinical trials evaluating interventions to improve compliance with lower glycated hemoglobin (HbA1c) in patients with type 1 diabetes according to intervention categories</p></caption><table frame="hsides" rules="groups"><thead><tr><th>Study</th><th>Sample</th><th>Intervention and Control groups</th><th>HbA1c changes/comments</th></tr></thead><tbody><tr><td>Psychological category</td><td colspan="3"></td></tr><tr><td>Ellis, 2005, 2007 [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR24">24</xref>] (4 published complementary reports)</td><td><italic>n</italic> = 127 Age = 13.3 years Diabetes duration = 5.3 years Male = 62 (48 %) White = 33 (26 %)</td><td>Intervention Multisystemic therapy: intensive and home- and community-based, originally designed for youths with antisocial behavior. Duration of intervention: 5.7 months Control Standard medical care: quarterly visit of multidisciplinary team</td><td>Intervention Baseline = 11.4 ± 2.2 % End-of-study = 10.8 ± 2.6 % Control Baseline = 11.3 ± 2.3 % End-of-study = 11.3 ± 2.3 % Significant reduction of HbA1c only in the intervention group Compliance evaluation of the psychological intervention: semi structured interview</td></tr><tr><td>Nansel, 2007 [<xref ref-type="bibr" rid="CR25">25</xref>]</td><td><italic>n</italic> = 81 Age =13.6 years Diabetes duration = 7.6 years Male = 36 (44 %) White = 69 (85 %)</td><td>Intervention “Diabetes Personal Trainer”: approach guided by principles of motivational interviewing, applied behavior analysis, and problem solving. Duration of intervention: 2 months Control Education plus standard diabetes care</td><td>No significant reduction in HbA1c in intervention and control groups, but absolute values were not described Compliance evaluation of the psychological intervention: modified version of Diabetes –Management Profile</td></tr><tr><td>Weinger, 2011 [<xref ref-type="bibr" rid="CR26">26</xref>]</td><td><italic>n</italic> = 110<sup>a</sup> Age = 46.6 years Diabetes duration = 23.7 years Male = 48 (48 %) White = 105 (96 %)</td><td>Intervention Structured behavioral intervention: five 2-hour sessions. Duration of intervention: 6 weeks Control Individual appointments with diabetes nurse and dietitian educators</td><td>Intervention Baseline = 9.0 ± 1.9 % End-of-study = 8.7 ± 1.2 % Control Baseline = 8.7 ± 0.6 % End-of-study = 8.5 ± 1.1 % Changes of HbA1c were described but statistical analysis was not reported<break></break>Compliance evaluation of the psychological intervention: frequency of diabetes self-care, 3-day pedometer readings, 24-hour diet recalls, average number of glucose checks.</td></tr><tr><td>Nansel, 2012 [<xref ref-type="bibr" rid="CR27">27</xref>]</td><td><italic>n</italic> = 390 Age = 12.5 years Diabetes duration = 4.8 years Male = 191 (49 %) White = 273 (70 %)</td><td>Intervention Clinic-integrated behavioral: designed to improve family diabetes management (WE-CAN manage diabetes). Duration of intervention: 24 months Control Standard medical care</td><td>Significant reduction of HbA1c occurred only in the intervention group, but absolute values were not described Compliance evaluation of the psychological intervention: semi structured interview</td></tr><tr><td>Mulvaney, 2010 [<xref ref-type="bibr" rid="CR28">28</xref>]</td><td><italic>n</italic> = 72 Age =15.1 years Diabetes duration: 6.3 years Male = 40 (56 %) White = 66 (92 %)</td><td>Intervention Learning, social-cognitive and self-determination management by website support. Duration of intervention: 11 weeks. Control Usual care</td><td>Intervention Baseline = 9.1 ± 1.9 % End-of –study = 9.1 ± 1.8 % Control Baseline = 8.2 ± 1.2 % End-of-study = 8.5 ± 1.3 % No significant reduction in HbA1c in intervention and control groups Compliance evaluation of the psychological intervention: The Diabetes Rating Scale</td></tr><tr><td>Franklin, 2006 [<xref ref-type="bibr" rid="CR29">29</xref>]</td><td><italic>n</italic> = 61 Age = 13.5 years Diabetes duration = 4.1 years Male = 34 (56 %) White = 59 (97 %) Results referred only to patients on conventional insulin arm</td><td>Intervention “Sweet talk”: motivational support network to deliver behavioral intervention through mobile. Duration of intervention: unclear Control Usual care</td><td>Intervention Baseline = 9.8 % End-of-study = 10.1 ± 1.7 % Control Baseline = 10.1 % End-of-study = 10.3 ± 1.7 % No significant reduction in HbA1c in intervention and control groups Compliance evaluation of the psychological intervention: self-report adherence</td></tr><tr><td>Telecare category</td><td colspan="3"></td></tr><tr><td>Montori, 2004 [<xref ref-type="bibr" rid="CR30">30</xref>]</td><td><italic>n</italic> = 31 Age = 43 years Diabetes duration = 17 years Male = 10 (32 %) White = no information</td><td>Intervention Monitoring blood glucose four times/day and transmitting recorded data twice a week with feedback from a nurse supervised by an endocrinologist 24 hours after the transmission. Duration of intervention: 6 months Control Same monitoring requested but without feedback</td><td>Intervention Baseline = 9.3 ± 1.3 % End-of-study = 7.8 ± 1.3 % Control Baseline = 8.8 ± 1.2 % End-of-study = 8.2 ± 1.2 % Significant reduction of HbA1c only in the intervention group Compliance evaluation of the telecare intervention: SMBG and insulin use</td></tr><tr><td>Lawson, 2005 [<xref ref-type="bibr" rid="CR31">31</xref>]</td><td><italic>n</italic> = 46 Age = 15.2 years Diabetes duration = 6.5 years Male = 26 (56 %) White = no information</td><td>Intervention Weekly standardized telephone contact with a diabetic nurse specialist to discuss blood sugar over the last week and performing insulin adjustments using standard rules and algorithms. Duration of intervention: 6 months Control Standard care with quarterly visit with a nurse and an endocrinologist</td><td>Intervention Baseline = 10 ± 1.3 % End-of-study = 9.4 ± 1.4 % Control Baseline = 9.7 ± 0 .6 % End-of-study = 9.2 ± 1.4 % No significant reduction of HbA1c in intervention and control groups Compliance evaluation of the telecare intervention: general adherence with diabetes management (blood glucose testing, insulin schedule, food plan, glucose goals, exercise)</td></tr><tr><td>Farmer, 2005 [<xref ref-type="bibr" rid="CR32">32</xref>]</td><td><italic>n</italic> = 93 Age = 23.8 years Diabetes duration = 12.1 years Male = 55 (59 %) White = no information</td><td>Intervention Clinical advice and structured specialized nurse counseling in response to real-time blood glucose test results. Duration of intervention: 9 months Control Data transmission without feedback</td><td>Intervention Baseline = 9.2 ± 1.1 % End-of-study = 8.6 ± 1.4 % Control Baseline = 9.3 ± 1.5 % End-of-study = 8.9 ± 1.4 % Significant reduction of HbA1c in intervention and control groups, without difference between them Compliance evaluation of the telecare intervention: SMBG</td></tr><tr><td>Landau, 2011 [<xref ref-type="bibr" rid="CR33">33</xref>]</td><td><italic>n</italic> = 70 Age = 15 years Diabetes duration = 5.7 years Male = 32 (46 %) White = no information</td><td>Intervention Weekly upload of the self-monitoring blood glucose and feedback from study coordinator. Parents were contacted if any change in the treatment was necessary. Duration of intervention: 6 months Control Data upload without study coordinator feedback</td><td>Intervention Baseline = 8.5 ± 1.4 % End-of-study = 8.5 ± 1.4 Control Baseline = 8.2 ± 1.1 % End-of-study = 8.4 ± 1.1 % No significant reduction of HbA1c in intervention and control groups Compliance evaluation of the telecare intervention: SMBG</td></tr><tr><td>Gay, 2006 [<xref ref-type="bibr" rid="CR34">34</xref>]</td><td><italic>n</italic> = 100 Age = 13.3 years Diabetes duration = 6.2 years Male = 32 (61 %) White = no information</td><td>Intervention Twice a month children went to a selected pharmacy to download data stored in their glucometer. Data was transmitted to a pediatric diabetologist and within 5 days feedback was provided. Duration of intervention: 6 months Control Usual follow-up</td><td>Intervention Baseline = 9.2 ± 1.1 % End-of-study = 9.1 ± 1.5 % Control Baseline = 9.2 ± 1 % End-of-study = 9.3 ± 1.2 % No significant reduction of HbA1c in intervention and control groups. There were problems with software installation Compliance evaluation of the telecare intervention: SMBG and insulin adjustments</td></tr><tr><td>Esmatjes, 2014 [<xref ref-type="bibr" rid="CR35">35</xref>]</td><td><italic>n</italic> = 154 Age = 31.7 years Diabetes duration = 17.7 years Male = 69 (44.9 %) White = no information</td><td>Intervention Five telematic visits, and management of the Medical Guard Diabetes (MGD) system (Pulso Ediciones, Barcelona, Spain) with data reports once a month and responses of diabetes team in the following 3 days with recommendations on treatment adjustments. Duration of intervention: 6 months Control All visits were in hospital and data were obtained on site during the visits</td><td>Intervention Baseline = 9.3 ± 1.5 % End-of-study = 8.7 ± 1.5 % Control Baseline = 9.2 ± 0.9 % End-of-study = 8.6 ± 0.9 % No significant reduction of HbA1c between intervention and control groups Compliance evaluation of the telecare intervention: self-care treatment adherence</td></tr><tr><td>Educational category</td><td colspan="3"></td></tr><tr><td>Cook, 2002 [<xref ref-type="bibr" rid="CR36">36</xref>]</td><td><italic>n</italic> = 53 Age = 14.6 years Diabetes duration = no information Male = 26 (49 %) White = 45 (85 %)</td><td>Intervention Small group education to teach adolescents to became more responsible with day-to-day diabetes care (Choices Program). Duration of intervention: 6 weeks Control Usual care</td><td>Intervention Baseline = 8.9 ± 1.3 % End-of-study = 8.3 ± 1.4 % Control Baseline = 9.3 ± 2 .1 % End-of-study = 9.0 ± 1.9 % No significant reduction of HbA1c in intervention and control groups at 6 months Compliance evaluation of the educational intervention: SMBG and Diabetes Problem Solving Questionnaire</td></tr><tr><td>Howe, 2005 [<xref ref-type="bibr" rid="CR37">37</xref>]</td><td><italic>n</italic> = 49 Age = 12.8 years Diabetes duration = no information Male = 28 (57 %) White = 27 (55 %)</td><td>Intervention Single educational intervention to provide families with basic diabetes management skills. Duration of intervention: one session Control Standard care with quarterly visit with a nurse practitioner and an endocrinologist</td><td>Intervention Baseline = 10.1 ± 1.2 % End-of-study = 9.7 ± 1.9 % Control Baseline = 10.2 ± 1.4 % End-of-study = 9.9 ± 1.6 % No significant reduction of HbA1c in intervention and control groups Compliance evaluation of the educational intervention: Adherence Clinician Checklist</td></tr><tr><td>Howe, 2005 [<xref ref-type="bibr" rid="CR37">37</xref>]</td><td><italic>n</italic> = 54 Age = 12.1 years Diabetes duration: no information Male = 29 (54 %) White = 28 (52 %)</td><td>Intervention Single educational intervention to provide families with basic diabetes management skills plus weekly phone calls for 3 months and then bimonthly. Study coordinator followed a standard protocol on the phone talking about problem-solving skills related to diabetes care. Duration of intervention: 6 months Control Standard care with quarterly visit with nurse practitioner and an endocrinologist</td><td>Intervention Baseline = 10 ± 1.4 % End-of-study = 9.5 ± 1.7 % Control Baseline = 10.2 ± 1.4 % End-of-study = 9.9 ± 1.6 % No significant reduction of HbA1c in intervention and control groups Adherence / Compliance evaluation: Adherence Clinician Checklist.</td></tr><tr><td>Weinger, 2011 [<xref ref-type="bibr" rid="CR26">26</xref>]</td><td><italic>n</italic> = 110<sup>b</sup> Age = 46.6 years Diabetes duration = 23.7 years Male = 48 (48 %) White = 105 (96 %)</td><td>Intervention Five 2-hour sessions of manual-based group diabetes education Duration of intervention: 6 weeks Control Individual appointments with diabetes nurse and dietitian educators</td><td>Results of HbA1c were described together for patients with type 1 and type 2 diabetes Compliance evaluation of the educational intervention: frequency of diabetes self-care, 3-day pedometer readings, 24-hour diet recalls, average number of glucose checks</td></tr><tr><td>Nunn, 2006 [<xref ref-type="bibr" rid="CR38">38</xref>]</td><td><italic>n</italic> = 123 Age = 11.6 years Diabetes duration = 3.7 years Male = 69 (56 %) White = no information</td><td>Intervention Bimonthly phone calls from a diabetes educator covering the three main topics insulin use, carbohydrate intake and blood glucose values with a written educational program. Duration of intervention: 7 months Control Usual care</td><td>Intervention Baseline = 8.2 ± 1.1 % End-of-study = 8.9 ± 1.3 % Control Baseline = 8.3 ± 1.01 % End-of-study = 8.8 ± 1.1 % No significant reduction of HbA1c in intervention and control groups at 6 months Compliance evaluation of the educational intervention: SBGM, limited screen time, exercise practice, rotation of injection sites, warrant bracelets worn</td></tr><tr><td>Psychoeducation category</td><td colspan="3"></td></tr><tr><td>Katz, 2014 [<xref ref-type="bibr" rid="CR39">39</xref>]</td><td><italic>n</italic> = 153 Diabetes duration = 12.8 years Male = 67 (44 %%) White = no information</td><td>Intervention 1 Psychoeducation was performed as 30-minute quarterly sessions with the patient, parent or guardian, and a non-medical care ambassador. Material was related to: family management of diabetes, problem-solving exercises and role-playing realistic expectations, glucose self-monitoring, avoidance of weight gain, and hypoglycemia. Duration of intervention: 2 years Intervention 2 Participants received monthly outreach by the care ambassador via phone or email, in addition to the quarterly diabetes care and ambassador care coordination. Duration of intervention: 2 years Intervention 3 Standard care including basic care coordination by the care ambassador (to assist in scheduling quarterly clinic visits)</td><td>Intervention 1 Baseline = 8.3 ± 1.4 % End-of-study = 8.6 ± 1.0 % Intervention 2 Baseline = 8.5 ± 1.4 % End-of-study = 8.8 ± 1.0 % Intervention 3 Baseline = 8.5 ± 1.4 % End-of-study = 8.6 ± 1.0 % No significant reduction of HbA1c in intervention and control groups at 2 years Compliance evaluation of the educational intervention: Diabetes Family Responsibility Questionnaire</td></tr></tbody></table><table-wrap-foot><p><sup>a</sup>Results referred to two out of three study arms: behavior versus individual care; HbA1c results were from 73 patients</p><p><sup>b</sup>Results referred to two out of three study arms: educational versus individual care; HbA1c results were from 73 patients</p></table-wrap-foot></table-wrap><table-wrap id="Tab3"><label>Table 3</label><caption><p>Meta-analysis: risk of bias in individual randomized clinical trials evaluating interventions to improve compliance to lower glycated hemoglobin (HbA1c) in patients with type 1 diabetes according to intervention category</p></caption><table frame="hsides" rules="groups"><thead><tr><th></th><th colspan="2">Selection bias</th><th>Performance bias</th><th>Detection bias</th><th>Attrition bias</th><th>Reporting bias</th></tr></thead><tbody><tr><td></td><td>Random sequence generation</td><td>Allocation concealment</td><td>Blinding of participant and personnel</td><td>Blinding of outcome assessment</td><td>Incomplete outcome data</td><td>Selective reporting</td></tr><tr><td>Psychology category</td><td colspan="6"></td></tr><tr><td> Ellis, 2005 –2007<sup>b</sup></td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Nansel, 2007</td><td>low</td><td>low</td><td>low</td><td>low</td><td>high</td><td>uncertain</td></tr><tr><td> Weinger, 2011<sup>a</sup></td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Nansel, 2011</td><td>low</td><td>low</td><td>high</td><td>uncertain</td><td>high</td><td>low</td></tr><tr><td> Mulvaney, 2010</td><td>low</td><td>low</td><td>uncertain</td><td>uncertain</td><td>uncertain</td><td>uncertain</td></tr><tr><td> Franklin, 2006</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>uncertain</td><td>low</td></tr><tr><td>Telecare category</td><td colspan="6"></td></tr><tr><td> Montori, 2004</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>uncertain</td><td>low</td></tr><tr><td> Lawson, 2005</td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Farmer, 2005</td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Landau, 2011</td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Gay, 2006</td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Esmatjes, 2014</td><td>low</td><td>low</td><td>uncertain</td><td>uncertain</td><td>uncertain</td><td>low</td></tr><tr><td>Education category</td><td colspan="6"></td></tr><tr><td> Cook, 2002</td><td>uncertain</td><td>uncertain</td><td>low</td><td>uncertain</td><td>uncertain</td><td>low</td></tr><tr><td> Howe, 2005</td><td>uncertain</td><td>uncertain</td><td>uncertain</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Weinger, 2011<sup>b</sup></td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr><tr><td> Nunn, 2006</td><td>low</td><td>low</td><td>low</td><td>low</td><td>uncertain</td><td>low</td></tr></tbody></table><table-wrap-foot><p><sup>a</sup>The same study had three arms evaluated as: psychology versus individual care and education versus individual care interventions</p><p><sup>b</sup>Four published complementary reports</p></table-wrap-foot></table-wrap></p><p>The data available from the reviewed RCTs allowed us to perform meta-analyses of psychological, educational, and telecare interventions. Only one trial evaluated combined psychological and educational interventions (psychoeducation category). Therefore, this trial was included only in the systematic review.</p><sec id="Sec10"><title>Psychological interventions</title><p>Systematic review of psychological interventions included six RCTs [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR29">29</xref>] and 783 patients aged 16.4 years (8 to 47), most of them, but one [<xref ref-type="bibr" rid="CR26">26</xref>] conducted in children and adolescents. Patients were mostly white (75 %) and about half of them were male with a mean diabetes duration of 7 years (4 to 24) years. Baseline HbA1c in intervention was 9.2 % (8.7 to 11.4 %) and 9.1 % (8.2 to 11.3 %) in the control group. Duration of intervention was 10.2 months (11 weeks to 24 months). The psychological approaches used in RCTs are described in Table <xref rid="Tab1" ref-type="table">1</xref>.</p><p>Nine studies were initially considered for inclusion in the psychological interventions meta-analysis [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR24">24</xref>, <xref ref-type="bibr" rid="CR26">26</xref>, <xref ref-type="bibr" rid="CR28">28</xref>]. However, the four studies conducted by Ellis et al. [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR24">24</xref>] presented complementary data and the same patients were evaluated. Then, we included data of only one study to avoid including the same individuals inappropriately twice in the pooled estimate. Therefore, four studies which presented baseline and end-of-study data were included in this meta-analysis.</p><p>The interventions promoted a significant reduction in HbA1c (MD −0.310 %; 95 % CI, −0.599, −0.021; <italic>P</italic> = 0.035). No heterogeneity was found in this analysis (<italic>I</italic><sup><italic>2</italic></sup> 0 %; <italic>P</italic> = 0.615).</p></sec><sec id="Sec11"><title>Telecare interventions</title><p>Systematic review of telecare interventions evaluated six RCTs [<xref ref-type="bibr" rid="CR30">30</xref>–<xref ref-type="bibr" rid="CR35">35</xref>], including 494 patients with mean age 25.8 (13 to 43 years). No information about ethnicity was provided and about half of patients were males. Diabetes duration was 11.43 years (5.7–17.2). The length of most studies was 6 months and only one lasted for 9 months. The description of telecare interventions used in RCTs is shown in Table <xref rid="Tab1" ref-type="table">1</xref>.</p><p>All six RCTs were included in the meta-analysis of telecare intervention. The HbA1c of patients submitted to telecare interventions was not reduced during trials (MD −0.124 %; 95 % CI, −0.268, 0.020; <italic>P</italic> = 0.090) (Fig. <xref rid="Fig2" ref-type="fig">2</xref>). No heterogeneity was found in this analysis (<italic>I</italic><sup><italic>2</italic></sup> 35.8 %; <italic>P</italic> = 0.168).<fig id="Fig2"><label>Fig. 2</label><caption><p>Forest plots of interventions to improve compliance with lower glycated hemoglobin (HbA1c) in patients with type 1 diabetes: <bold>a</bold> Psychological. <bold>b</bold> Telecare. <bold>c</bold> Education categories</p></caption><graphic xlink:href="13063_2016_1207_Fig2_HTML" id="MO2"></graphic></fig></p></sec></sec><sec id="Sec12"><title>Educational interventions</title><p>Systematic review of educational interventions included four RCTs [<xref ref-type="bibr" rid="CR26">26</xref>, <xref ref-type="bibr" rid="CR36">36</xref>–<xref ref-type="bibr" rid="CR38">38</xref>] and 352 patients 19.6 years old (12 to 46). Trials were conducted mainly in children and adolescents. Patients were mostly white (65 %) and about half of them were male. Mean diabetes duration was described in only two studies. The duration of intervention varied from a single session to 12 months. The educational interventions used in RCTs are described in Table <xref rid="Tab1" ref-type="table">1</xref>.</p><p>In the meta-analysis of included RCTs, five interventions were evaluated in four trials. No change in HbA1c was observed with educational approaches (MD −0.001 %; 95 % CI, −0.202, 0.200; <italic>P</italic> = 0.990) (Fig. <xref rid="Fig2" ref-type="fig">2</xref>). No heterogeneity was found in this analysis (<italic>I</italic><sup><italic>2</italic></sup> 0 %; <italic>P</italic> = 0.426).</p><sec id="Sec13"><title>Psychoeducation intervention</title><p>One trial combined psychological and educational intervention [<xref ref-type="bibr" rid="CR39">39</xref>] including 153 patients with type 1 diabetes (44 % males, age 12.8 years) and evaluated three intervention arms. The psychoeducation arm consisted in 30-minute quarterly sessions. Psychoeducational material was related to family management of diabetes, avoiding perfectionism and setting realistic goals (psychological intervention), and glucose self-monitoring, weight gain, and hypoglycemia (educational intervention). Psychoeducational intervention was compared to usual care or usual care plus monthly phone calls or email reinforcements. Care from a non-medical ambassador occurred in all study arms. There was no difference in HbA1c among groups at 2 years.</p></sec><sec id="Sec14"><title>Subgroup analyses</title><p>Twelve of the 18 meta-analyzed trials were conducted only in children and adolescents. We re-ran analyses maintaining only these 12 RCTs [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR24">24</xref>, <xref ref-type="bibr" rid="CR28">28</xref>, <xref ref-type="bibr" rid="CR29">29</xref>, <xref ref-type="bibr" rid="CR33">33</xref>–<xref ref-type="bibr" rid="CR37">37</xref>]. Results of these meta-analyses are described in Table <xref rid="Tab4" ref-type="table">4</xref>. No intervention (psychology, telecare, education) was able to reduce HbA1c in this age specific population. No heterogeneity was found in any meta-analysis.<table-wrap id="Tab4"><label>Table 4</label><caption><p>Subgroup meta-analyses: changes in glycated hemoglobin (HbA1c) (%) in randomized clinical trials evaluating interventions to improve compliance with lower HbA1c in children and teenagers with type 1 diabetes</p></caption><table frame="hsides" rules="groups"><thead><tr><th rowspan="2">Type of intervention</th><th rowspan="2">Number of studies</th><th rowspan="2">Number of patients</th><th>MD</th><th rowspan="2">95 % CI</th><th rowspan="2"><italic>P</italic></th></tr><tr><th>HbA1c</th></tr></thead><tbody><tr><td>Psychological [<xref ref-type="bibr" rid="CR21">21</xref>–<xref ref-type="bibr" rid="CR24">24</xref>, <xref ref-type="bibr" rid="CR28">28</xref>, <xref ref-type="bibr" rid="CR29">29</xref>]</td><td>3</td><td>239</td><td>-0.34%</td><td>-0.72 to 0.035 %</td><td char="." align="char">0.083</td></tr><tr><td>Telecare [<xref ref-type="bibr" rid="CR32">32</xref>–<xref ref-type="bibr" rid="CR35">35</xref>]</td><td>3</td><td>554</td><td>-0.18%</td><td>-0.40 to 0.03 %</td><td char="." align="char">0.098</td></tr><tr><td>Educational [<xref ref-type="bibr" rid="CR36">36</xref>–<xref ref-type="bibr" rid="CR38">38</xref>]</td><td>4</td><td>631</td><td>0.046</td><td>-0.80 to 0.272</td><td char="." align="char">0.689</td></tr></tbody></table><table-wrap-foot><p><italic>MD</italic> mean differences</p></table-wrap-foot></table-wrap></p></sec></sec></sec><sec id="Sec15" sec-type="discussion"><title>Discussion</title><p>This was a systematic review of interventions aiming to reduce HbA1c in patients with type 1 diabetes by improving compliance with therapy. The review considered 1782 individuals from 19 RCTs. We were able to perform three meta-analyses according to the type of interventions: psychology, telecare, and education. Psychological interventions were associated with HbA1c reduction (MD −0.310; 95 % CI, −0.599 to −0.0210, <italic>P</italic> = 0.035) but not meta-analyses of telecare (MD −0.124 %; 95 % CI, −0.268, 0.020; <italic>P</italic> = 0.090) or educational (MD −0.001; 95 % CI, −0.202, 0.200; <italic>P</italic> = 0.990) interventions.</p><p>Tight glycemic control is difficult to obtain in type 1 diabetic patients and any intervention that reduces HbA1c is extremely helpful in controlling their diabetes. We identified two other systematic reviews on adherence in the medical literature [<xref ref-type="bibr" rid="CR13">13</xref>, <xref ref-type="bibr" rid="CR14">14</xref>]. One of them analyzed cross-sectional studies [<xref ref-type="bibr" rid="CR13">13</xref>]. The other study evaluated adherence or self-management promoting strategies. However, the authors performed a meta-analysis including all different categories of intervention together and showed no improvement in glycemic control [<xref ref-type="bibr" rid="CR14">14</xref>]. We believe that stratifying intervention categories (such as psychology, education, telecare), as we did in the current study, is a more adequate statistical approach. In addition, it is important to emphasize that our literature search method was quite unique: we performed an open search for RCTs that improved patient compliance instead of searching for specific interventions. This strategy could explain the differences between our results and the previous reviews. We also excluded crossover trials because it is hard to perform an adequate washout when dealing with subjective interventions.</p><p>A systemic review of psychological and educational interventions in adolescents with type 1 diabetes [<xref ref-type="bibr" rid="CR40">40</xref>] seemed to reduce HbA1c for both interventions but the confidence interval for HbA1c changes was quite large. Furthermore, this review was not projected to evaluate whether the studied interventions were associated with patients’ compliance with the diabetes treatment. Regarding telecare intervention, a meta-analysis conducted in patients with type 1 diabetes did not reduce HbA1c [<xref ref-type="bibr" rid="CR30">30</xref>], similar to our results. However, that study was not aimed to reduced HbA1c [<xref ref-type="bibr" rid="CR30">30</xref>], and once again this study was not designed to evaluate compliance.</p><p>Most children and teenagers with type 1 diabetes do not meet traditional glycemic control targets [<xref ref-type="bibr" rid="CR11">11</xref>] and recently the American Diabetes Association reduced HbA1c goals for youth [<xref ref-type="bibr" rid="CR12">12</xref>]. Interestingly, in our data search we found that most studies were performed in children and adolescents. Therefore, we decided to perform a subgroup analysis including only these patients. Indeed, the management of children and teenagers with diabetes usually has peculiarities, including non-pharmacological interventions (e.g., family involvement) [<xref ref-type="bibr" rid="CR18">18</xref>]. Unfortunately, we were not able to confirm benefits of any studied intervention in this specific population similar to those described by other authors [<xref ref-type="bibr" rid="CR40">40</xref>]. Inclusion of a greater number of studies in pediatric patients could have shown improvement in glycemic control since there is still a clear trend to lower HbA1c by psychological intervention according to our subgroup analysis.</p><p>A possible limitation of our systematic review could be the small number of studies in each intervention category. Since we performed complete-case analyses [<xref ref-type="bibr" rid="CR48">48</xref>], the missing data in some of reviewed trials precluded their inclusion in our meta-analyses. In theory the choice to use only studies that report baseline and final values could lead to the possibility of selective reporting [<xref ref-type="bibr" rid="CR43">43</xref>]. Indeed, analyses based on changes from baseline will be more efficient and powerful than comparisons of final values [<xref ref-type="bibr" rid="CR43">43</xref>], especially when analyzing HbA1c values. The quality of included studies could represent a weakness in our meta-analyses. Nevertheless, only the study of Nansel et al. [<xref ref-type="bibr" rid="CR27">27</xref>] included a psychological intervention and there were two high domain biases: blinding bias, which was not truly applicable to this type of intervention, and incomplete data. All other studies included revealed a low or uncertain bias risk. Contact with non-responding authors remains a problem in performing meta-analyses since we could not recover any missing data after personal contact. It would be interesting to compare all included trials through a network meta-analysis. However, different strategies without a common comparator prevented us from performing this analysis.</p></sec><sec id="Sec16" sec-type="conclusion"><title>Conclusion</title><p>We performed this systematic review because there was no clear information available regarding which kind of intervention should be used to improve compliance with general diabetes treatment aimed at lowering HbA1c (improvement of glycemic control). Unfortunately, so far we could only demonstrate psychological intervention as the sole evidence-based recommendation; the number of included studies was relatively low but their quality allowed us to conclude that this tool can be useful in the management of diabetic patients. In conclusion, we demonstrated that in patients with type 1 diabetes psychological interventions to improve patients’ compliance with diabetes treatment did improve glycemic control.</p></sec></body><back><app-group><app id="App1"><sec id="Sec17"><title>Appendix</title><sec id="Sec18"><title>Research strategy</title><sec id="Sec19"><title>Medline</title><p>((((“Randomized Controlled Trial”[Publication Type]) AND “Diabetes Mellitus, Type 1”[Mesh]) AND “Patient Compliance”[Mesh]) AND “Hemoglobin A, Glycated”[Mesh])</p></sec></sec></sec></app><app id="App2"><sec id="Sec20"><title>Additional file</title><p><media position="anchor" xlink:href="13063_2016_1207_MOESM1_ESM.doc" id="MOESM1"><label>Additional file 1:</label><caption><p><bold>PRISMA 2009 Checklist.</bold> (DOC 63 kb)</p></caption></media></p></sec></app></app-group><glossary><title>Abbreviations</title><def-list><def-item><term>HbA1c</term><def><p>glycated hemoglobin</p></def></def-item><def-item><term>MD</term><def><p>mean differences</p></def></def-item><def-item><term>PRISMA</term><def><p>Preferred Reporting Items for Systematic Reviews and Meta-Analyses</p></def></def-item><def-item><term>RCT</term><def><p>randomized controlled clinical trial</p></def></def-item></def-list></glossary><fn-group><fn><p><bold>Competing interests</bold></p><p>The authors declare that they have no competing interests.</p></fn><fn><p><bold>Authors’ contributions</bold></p><p>LVV and MJA were engaged in conception and design, data extraction, statistical analyses and interpretation of data and drafting of the manuscript. MBG was involved in conception, data interpretation, and manuscript revision. LZ and EJP reviewed the manuscript and researched the data. LVV is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors also read and approved the final manuscript.</p></fn></fn-group><ack><title>Acknowledgements</title><p>Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), and Fundo de Incentivo à Pesquisa (FIPE) of Hospital de Clínicas de Porto Alegre (HCPA).</p></ack><ref-list id="Bib1"><title>References</title><ref id="CR1"><label>1.</label><mixed-citation publication-type="other">The Diabetes Control and Complications Trial Research Group. 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